Modernizing CAPA Systems to Achieve Meaningful ImprovementModernizing CAPA Systems is not just a regulatory demand, but a strategic imperative for organizations seeking to thrive in a landscape where quality is paramount. Business and consumer attitudes on trust as it applies to safety, pricing, and performance in the age of instant reviews mandates organizations be fully compliant with their Quality systems and be able to demonstrate such commitment comprehensively. Check the data Recently reviewed data from the last 10 years of the U.S. FDA’s oversight highlights a consistent gap in Quality Management Systems (QMS), specifically around CAPA procedures. The data explained in our 3-minute video reveals a critical need for systemic improvement. In the review, nearly four in ten organizations — …
Challenges to Effective CAPA Systems
A disconcerting trend in Quality Management Systems has been revealed during a review of the last 10 years of FDA Warning letter data. This review of data from 2023 and the 9 years prior shows that a significant average of 37% of organizations have faced criticism for having ‘inadequately established’ CAPA (Corrective and Preventive Action) systems.
Are you Avoiding the Digital Factory Trend?
Recently, as part of the Watercooler Wisdom series, Horizon’s Frances Donnelly was joined by Sandy Wickman, Senior Business Consultant from LBMC Technology Solutions, to discuss the Digital Factory trend and talk about some real-world results and findings. View the full interview here. GP’s Watercooler Wisdom series was designed to present brief, targeted, expert-led discussions to business owners about challenges they may be facing. You can view the past and upcoming sessions of the series here. Resistance to Digital Factory Initiatives Manufacturers do not typically… Read More
A Faster Way to Generate a COA: How We Make it Happen
When new Quality Essentials Suite customers compare our process for generating Certificates of Analysis to their legacy processes, they frequently see productivity gains of 50% or better. If we add the impact of more efficient error correction, that productivity improves even more. When we were developing our Quality Management Solution, our goal was to be more than just another quality control data collection and analysis product. We went looking for tasks related to the use of quality control and quality … Read More
Productivity Improvements for Quality Management
The reality is, now more than ever, we all want to be more productive, more accurate, and help reduce the stress of getting the job done. We want to find tools – tools that everyone can agree on – that meet our budget constraints for time and money. And we want to those tools to actually allow us to achieve the benefits promised. Right now, when many of us are operating with systems that are particularly stressed, we are more likely to be feeling high levels … Read More